ASTM F2401-16
(Practice)Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
SIGNIFICANCE AND USE
5.1 This practice is intended to be used as a guide for the design, configuration, and operation of security checkpoints to minimize exposure of ambulatory medical devices to the electromagnetic fields emitted by metal detector security systems. Guidance is presented for signage and information to help identify persons with ambulatory medical devices and process them through the security checkpoint.
5.2 This practice is intended to help in the training of checkpoint screeners to address the concerns of persons with ambulatory medical devices and to respond to their needs.
5.3 This practice is intended to aid the medical community in advising medical device users who may be affected to identify themselves at security checkpoints so their concerns may be addressed.
5.4 This practice is intended to aid medical device manufacturers to provide consistent information for medical device users, patients, and checkpoint screeners.
SCOPE
1.1 The following practice is intended to address the needs and concerns of persons with implanted, active, medical devices or active ambulatory medical devices, as well as passive implanted medical devices, while maintaining the integrity of the security checkpoint.
1.2 Active and passive implanted medical devices are being used at an increasing rate as a means to prolong and improve quality of life. Although these medical devices are typically designed to operate in the electromagnetic environment experienced in daily life, there is a potential for the disruption of active medical device function when exposed to certain electromagnetic fields emitted by commonly encountered electrically powered products, including handheld and walk-through metal detectors used in security checkpoint screening. In addition, some active or passive implanted devices may trigger the unintended alarm of the metal detector.
1.3 The values stated in SI units are to be regarded as the standard. The values shown in parentheses are for information only.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2401 − 16
Standard Practice for
Security Checkpoint Metal Detector Screening of Persons
1
with Medical Devices
This standard is issued under the fixed designation F2401; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ISO 14708-1 Implants for surgery – Active implantable
medical devices – Part 1: General requirements for safety,
1.1 The following practice is intended to address the needs
marking and for information to be provided by the
and concerns of persons with implanted, active, medical
manufacturer
devices or active ambulatory medical devices, as well as
ISO 14708-2 Implants for surgery – Active implantable
passive implanted medical devices, while maintaining the
medical devices – Part 2: Cardiac pacemakers
integrity of the security checkpoint.
ISO 14708-3 Implants for surgery – Active implantable
1.2 Active and passive implanted medical devices are being
medical devices – Part 3: Implantable neurostimulators
used at an increasing rate as a means to prolong and improve
ISO 14708-4 Implants for surgery – Active implantable
quality of life. Although these medical devices are typically
medical devices – Part 4: Implantable infusion pumps
designed to operate in the electromagnetic environment expe-
ISO 14708-5 Implants for surgery – Active implantable
rienced in daily life, there is a potential for the disruption of
medical devices – Part 5: Circulatory support devices
active medical device function when exposed to certain elec-
ISO 14708-6 Implants for surgery – Active implantable
tromagnetic fields emitted by commonly encountered electri-
medical devices – Part 6: Particular requirements for
cally powered products, including handheld and walk-through
active implantable medical devices intended to treat tach-
metal detectors used in security checkpoint screening. In
yarrhythmia (including implantable defibrillators)
addition, some active or passive implanted devices may trigger
ISO 14708-7 Implants for surgery – Active implantable
the unintended alarm of the metal detector.
medical devices – Part 7: Particular requirements for
1.3 The values stated in SI units are to be regarded as the
cochlear implant systems
standard. The values shown in parentheses are for information
only.
3. Terminology
1.4 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
3.1.1 active medical devices, n—electrically powered medi-
responsibility of the user of this standard to establish appro-
cal devices, usually employing electronic circuitry, for human
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. physiological monitoring or to deliver medical treatment or
therapy such as drugs or electrical stimulation. These devices
2. Referenced Documents
can be implanted, patient worn, or both.
2
2.1 ISO Standards: 3.1.2 ambulatory medical devices, n—any medical device
ISO 14117 Active implantable medical devices – Electro-
(active or nonactive) that can be body mounted, worn,
magnetic compatibility – EMC test protocols for implant- implanted, or otherwise mobile with the patient and thus
able cardiac pacemakers, implantable cardioverter
subject to screening at the security checkpoint.
defibrillators, and cardiac resynchronization devices
3.1.3 archway, n—physical structure of a walk-through
metal detector.
1
This practice is under the jurisdiction of ASTM Committee F12 on Security
3.1.4 electromagnetic field, n—when referenced in this
Systems and Equipment and is the direct responsibility of Subcommittee F12.60 on
practice, it describes the energy field created by the metal
Controlled Access Security, Search, and Screening Equipment.
detector as a means to produce a response to materials with
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 2004. Last previous edition approved in 2010 as F2401– 04 (2010).
electrical conductivity or magnetic susceptibility, or both. The
DOI: 10.1520/F2401-16.
electromagnetic fields used in metal detectors for security
2
Available from International Organization for Standardization (ISO), ISO
screening applications are typically low frequency and vary
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Geneva, Switzerland, http://www.iso.org. with time and locations.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C70
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2401 − 04 (Reapproved 2010) F2401 − 16
Standard Practice for
Security Checkpoint Metal Detector Screening of Persons
1
with Medical Devices
This standard is issued under the fixed designation F2401; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 The following practice is intended to address the needs and concerns of persons with implanted, active, medical devices or
active ambulatory medical devices, as well as passive implanted medical devices, while maintaining the integrity of the security
checkpoint.
1.2 Active and passive implanted medical devices are being used at an increasing rate as a means to prolong and improve quality
of life. Although these medical devices are typically designed to operate in the electromagnetic environment experienced in daily
life, there is a potential for the disruption of active medical device function when exposed to certain electromagnetic fields emitted
by commonly encountered electrically powered products, including handheld and walk-through metal detectors used in security
checkpoint screening. In addition, some active or passive implanted devices may trigger the unintended alarm of the metal detector.
1.3 The values stated in SI units are to be regarded as the standard. The values shown in parentheses are for information only.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ISO Standards:
ISO 14117 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac
pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices
ISO 14708-1 Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and
for information to be provided by the manufacturer
ISO 14708-2 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
ISO 14708-3 Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
ISO 14708-4 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pumps
ISO 14708-5 Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
ISO 14708-6 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable
medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 14708-7 Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear implant
systems
3. Terminology
3.1 Definitions:
3.1.1 active medical devices, n—electrically powered medical devices, usually employing electronic circuitry, for human
physiological monitoring or to deliver medical treatment or therapy such as drugs or electrical stimulation. These devices can be
implanted, patient worn, or both.
3.1.2 ambulatory medical devices, n—any medical device (active or nonactive) that can be body mounted, worn, implanted, or
otherwise mobile with the patient and thus subject to screening at the security checkpoint.
1
This practice is under the jurisdiction of ASTM Committee F12 on Security Systems and Equipment and is the direct responsibility of Subcommittee F12.60 on
Controlled Access Security, Search, and Screening Equipment.
Current edition approved May 1, 2010Oct. 1, 2016. Published May 2010October 2016. Originally approved in 2004. Last previous edition approved in 20042010 as
F2401F2401– 04. 04 (2010). DOI: 10.1520/F2401-04R10.10.1520/F2401-16.
2
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2401 − 16
3.1.3 archway, n—physical structure of a walk-through metal detector.
3.1.4 electromagnetic field, n—when referenced in this practice, it describes
...
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